Merck must feel like it’s waiting for Godot. The drugmaker got another wait-and-see notice from FDA in its bid to broaden use of Gardasil, the human papillomavirus vaccine, to women ages 27 to 45. Merck had expected to get word from the agency next week. Now, it says FDA will decide by year’s end.

“We’re continuing our dialogue with the FDA,” Merck spokeswoman Pam Eisele told Dow Jones. And it’s been a long dialogue. The company originally asked to market Gardasil to older women two years ago. As you know, the vaccine is currently approved to prevent HPV infection in girls and young women ages 9 to 26. In boys and young men of the same age, it’s approved as a genital warts preventive.

Back then, Merck submitted two-year data on the vaccine’s ability to prevent precancerous lesions caused by certain strains of HPV. The FDA wanted longer-term data. Merck turned in that data to FDA late last year and released it to the public in February, Dow Jones notes. The efficacy rate after four years of follow up was 88.7 percent compared with 91 percent after two years.

Gardasil was expected to be a huge hit for Merck, and though sales started out strong, they’ve tapered off. Recently, a study found that only 30 percent of eligible girls and young women had received the vaccine, despite intensive marketing campaigns. Broadening use of the shot–to males and older women–is part of the company’s strategy for turning the sales trend upward.

Source: FiercePharma

Popularity: 2% [?]

HPV test will be combined with Accuri’s flow cytometer to identify those whose infection is progressing to cancer.

IncellDx and Accuri Cytometers are coupling technologies to offer a cervical cancer screening test. Under the supply agreement, IncellDx’ HPV OncoTect™ E6, E7 mRNA test will be combined with the Accuri C6 Flow Cytometer®.

The HPV OncoTect E6, E7 mRNA test quantifies overexpression of E6/E7 mRNA in each cell as well as the total proportion of cells that are overexpressing. This information may provide a more specific indication of whether an HPV infection is transforming into cervical cancer, according to the companies.

HPV OncoTect can be used on routine liquid-based cytology samples and provides results in about 3.5 hours, IncellDx reports. An automation upgrade is also available that allows 96 samples to be processed in two hours.

It is CE marked and is available in Europe, South America, and Southeast Asia. Neither the Accuri C6 nor the HPV OncoTect E6, E7 mRNA kit has been cleared by the FDA.

“The robust, benchtop flow cytometer system has demonstrated excellent performance when combined with reagents from the HPV OncoTect E6, E7 mRNA kit,” says Bruce K. Patterson, M.D., CEO of IncellDx. “With this agreement IncellDx will have an automated, complete solution for cervical cancer screening, with the potential to be widely disseminated in the global market.”

The C6 flow cytometer also performs additional tests from the IncellDx product line, including the HIVTROPISM Probe and the HCVVR Viral Reservoirs Probe. These probes are currently available for research use only.

Source: GEN

Popularity: 3% [?]

At-home screening tests for the virus responsible for most cervical cancers could detect many more cases of the disease, say Dutch researchers.

Although cervical screening programmes have cut deaths, not all women take up the invite from the GP.

But self-test kits for human papillomavirus (HPV) could double the number of women diagnosed, the British Medical Journal reported.

Trials of self-testing for HPV are currently being done in the UK.

There are more than 100 types of HPV, which is sexually transmitted, but only 13 of them are known to cause cancer.

Although most HPV infections clear up by themselves, in some women it persists and cause damage to cells which may eventually develop into cervical cancer.

A vaccine against the two main types of HPV was introduced in the UK in 2008 for schoolgirls.

But the NHS has also been piloting HPV testing as an “add-on” to traditional screening – to pick out those most at risk.

Test kit

In the latest study almost 28,000 Dutch women who had not responded to two invites to attend the regular screening programme were sent an at-home screening kit for HPV.

A smaller group were sent a third invitation for routine screening.

More than a quarter of those sent kits returned a completed test kit, compared with only one in seven who responded in the recall group.

Those who self-tested and had a positive result were then referred for further tests.

Importantly, those women who had also not taken up the offer of the previous round of screening had a higher risk of abnormal changes in their cervix.

The researchers said more than half of cervical cancers in countries with screening programmes are diagnosed in women who have not attended routine testing.

Stephen Duffy, Cancer Research UK’s professor of cancer screening, said: “While it’s important for women to attend cervical screening appointments, some find it difficult to do so for cultural or other reasons.

“For these women, self-sampling for HPV may be an option.

“Its acceptability and effectiveness are currently being researched here in the UK.”

Source: BBC NEWS

Popularity: 3% [?]

The Associated Press has put out a helpful list of Merck’s top-selling drugs for the fourth quarter, now that it has merged with Schering-Plough. So we thought we’d take a look at the other megamerger–Pfizer and Wyeth–and Merck’s list, too. The names on both lists are familiar, and you’ll notice that each list includes some drugs brought in by the respective mergers. Here’s Pfizer’s list to start:

• Lipitor, cholesterol drug, $3.175 billion, a 1 percent increase over the same period last year;
• Lyrica, for fibromyalgia and nerve pain, $820 million, a 17 percent increase;
• Celebrex, an arthritis pain drug, $669 million, up 1 percent;
• Viagra, erectile dysfunction, $549 million, up 9 percent;
• Xalatan/Xalacom, eye pressure, $499 million, up 10 percent;
• Norvasc, for high blood pressure, $486 million, down 10 percent;
• Zyvox, antibiotic, $330 million, up 16 percent;
• Detrol/Detrol LA, overactive bladder, $309 million, down 1 percent;
• Sutent, cancer treatment, $293 million, up 33 percent; and
• Geodon/Zeldox, antipsychotics, $289 million, up 5 percent.                 Now, here’s the Merck version, from the AP (percentages ours):
• Singulair, Asthma/Allergies, $1.26 billion, up more than 12 percent;
• Cozaar/Hyzaar, high blood pressure, $955 million, up about 8 percent;
• Januvia/Janumet, diabetes, $760 million, up close to 43 percent;
• Remicade, rheumatoid arthritis, $635 million, up about 29 percent;
• Zetia, cholesterol, $614 million, up 10 percent;
• Vytorin, cholesterol, $577 million, up roughly 2 percent;
• Temodar, cancer treatment, $292 million, up close to 21 percent;
• Nasonex, allergies, $286 million, up about 2 percent;
• Fosamax, osteoporosis, $285 million, down 10 percent; and
• Gardasil, HPV vaccine, $277 million, down 3 percent.

Source: FiercePharma

Popularity: 7% [?]

Merck hasn’t given up on broader use of its HPV vaccine in women. The company has delivered a new batch of info to the FDA in support of Gardasil use in women aged 27 to 45. The vaccine–which wards off two strains of the virus that cause cervical cancer and two others that spawn genital warts–is already OK’d for marketing to females from 9 years to 26 years.

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Merck recently won another indication for Gardasil: For use in boys and young men to prevent genital warts. That’s a nice expansion, but lacks the urgency that cancer prevention lends to use in females. Limited to marketing to women under 26–and now young males–Merck has seen Gardasil sales drop. Globally, revenues from the vaccine fell 22 percent, Reuters reports, to $311 million in Q3 of 2009.

Meanwhile, Merck has been trying to stay one step ahead of GlaxoSmithKline and its Cervarix shot, which won the FDA nod last year. Competition from Cervarix is one reason why Gardasil sales have slipped.

All of this is why Merck is so doggedly pursuing the chance to market Gardasil to more adult women. It’s been turned down twice; most recently, FDA said it wouldn’t approve the new indication without data from a 48-month study. And that’s the trial data Merck delivered, before the end of 2009. News could come around midyear, because FDA tends to take around six months to review supplemental data, the company said.

Source: FiercePharma

Popularity: 3% [?]

The HPV vaccine saga continues. Less than a week after we got the FDA nod on GlaxoSmithKline’s Cervarix shot and a new use in males for Merck’s Gardasil, the Centers for Disease Control and Prevention has weighed in. And though the public-health agency sided with FDA on Cervarix, it wasn’t convinced that Gardasil should get routine use in boys and young men.

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Here’s the scoop: The CDC’s advisory panel recommended Cervarix for use in girls and women to prevent cervical cancer. But the committee said it wouldn’t recommend routine use of Gardasil to prevent genital warts in boys and young men, the use FDA recently approved. (Cervarix protects against the cancer-causing strains of HPV, while Gardasil also targets two strains that cause genital warts.) Doctors can use it if they want, but aren’t urged to do so.

The CDC rulings are significant because insurers often won’t pay for vaccines without the agency’s recommendation. So Cervarix is good to go on that score, while Gardasil-for-boys isn’t. But the CDC panel did recommend that Gardasil-for-boys be included in the government-funded Vaccines for Children program. So Medicaid will pay for that use, and other payers may pick up the tab based on that decision.

Source: FiercePharma

Popularity: 4% [?]

Ready for the HPV vaccine smackdown? GlaxoSmithKline finally won U.S. approval for its cervical cancer shot Cervarix, just as Merck nabbed a new indication for its competing vaccine Gardasil. Will Cervarix be able to capture significant market share in the U.S.? Or would Glaxo be better served by focusing on new international markets such as Japan?

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Up to now, Cervarix has captured only about one-sixth the worldwide sales that Gardasil has racked up. And the Glaxo shot is handicapped by Gardasil’s first-to-market advantage in the U.S. Indeed, the U.S. market may not be as lucrative as either drugmaker hoped; Gardasil itself has been lagging, despite the fact that only about one-third of eligible girls and young women have yet been vaccinated.

To combat that lag, Merck has been campaigning for broader use of its HPV shot, which protects against strains that cause genital warts, as well as those implicated in cervical cancer. Hence its new indication as a genital-warts preventative in boys and young men. Obviously, Cervarix doesn’t have that option, because it targets the cancer-causing strains only.

But Glaxo just won Japanese approval for the vaccine, giving it first-to-the-party advantage in the world’s second-largest drug market. We’ll just have to wait and see whether either vaccine can generate new momentum, either in the U.S. or elsewhere.

Source: FiercePharma

Popularity: 3% [?]

FDA has approved GlaxoSmithKline’s (GSK) HPV vaccine Cervarix. It is indicated for the prevention of cervical precancers and cervical cancer associated with HPV types 16 and 18 for use in girls and young women between the ages of 10 and 25.

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Cervarix was shown to be 93% efficacious in the prevention of cervical precancers associated with HPV 16 or 18 in women without evidence of current infection with or prior exposure to the same HPV type at the time of vaccination.

The FDA’s sanction of Cervarix was based on data from clinical trials in more than 30 countries involving a diverse population of nearly 30,000 girls and young women receiving the vaccine.

To date Cervarix has been approved in 100 countries around the world, including the 27 member states of the EU, Australia, Brazil, South Korea, Mexico, and Taiwan. It is administered in a three-dose schedule that should be completed within six months of the initial dose.

Source: GEN News

Popularity: 3% [?]

The FDA approved Merck’s Gardasil vaccine for use in boys and men ages 9-26, the company said today. The vaccine protects against some strains of HPV, the virus that causes cervical cancer in women; today’s approval was for using the vaccine to prevent genital warts, which are also caused by HPV.

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The vaccine is given in three doses, at $130 per dose — a price that may seem a bit high for reducing the risk of getting warts. But there are other theoretical reasons why there might be a benefit to vaccinating boys.

For one thing, because HPV is sexually transmitted, vaccinating boys might reduce the risk that unvaccinated girls would get HPV. For another, some types of cancer that occur in men have been linked to HPV, so vaccination might reduce the risk of developing these cancers. But neither of these possible benefits has been proven in clinical trials.

Also today, the FDA approved GlaxoSmithKline’s Cervarix for use in girls and women age 10 to 25. Cervarix is another HPV vaccine, and so is likely to provide some competition for Merck’s Gardasil, which until now has been the only HPV vaccine on the market in this country.

The FDA has raised concerns about a higher rate of miscarriages among girls and women who received Cervarix and said it couldn’t rule out a “small effect” on pregnancies, Dow Jones Newswires notes. The agency said it would require safety study to monitor the issue.

A CDC vaccine advisory committee meeting next week may vote on whether to recommend the use of Cervarix in girls and women. The committee may also vote on whether to recommend the use of Gardasil in boys and men.

Source: The Wall Street Journal

Popularity: 3% [?]

An FDA advisory panel today voted to recommend approval of GlaxoSmithKline’s Cervarix vaccine for use against the two strains of human papillomavirus (HPV) that cause 70% of cervical cancers.

In a separate action, the Vaccines and Related Biologics Committee recommended that the agency okay Merck’s application to extend the use of its HPV vaccine, Gardasil, against genital warts in males ages 9 through 26.

The panel’s near unanimous vote Wednesday on the use of Cervarix against HPV types 16 and 18 in females ages 15 to 26 makes it likely that the FDA will ultimately approve the first competitor to Gardasil, which has been used for three years in girls and women from 9 to 26 years of age to ward off four strains of HPV.

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The FDA is not bound by the recommendations of its panel of outside experts, but usually follows the committee’s advice.

The panel voted 12-1 that the manufacturer had demonstrated the effectiveness of Cervarix and 11-1 that it had demonstrated safety.

However, members of the panel pressed for strong aftermarket follow-up after discussing data that showed a somewhat higher rate of miscarriages around the time of vaccination and a small number of neurological problems.

Cervarix has already been approved in 98 countries.

FDA staff documents discussed by the committee indicated that Cervarix is effective in preventing genital dysplasias associated with HPV 16 and/or 18 in women ages 15 to 25 who are naive to those HPV types.

The FDA staff also noted that Cervarix might be effective in reducing genital dysplasias related to HPV 31, but that didn’t come up in the vote.

The FDA conclusions are based on findings from the already-reported PATRICIA trial — short for PApilloma TRial against Cancer in young Adults — which enrolled more than 18,000 women in 14 countries.

The primary endpoint was vaccine efficacy against cervical intraepithelial neoplasia associated with HPV 16 or HPV 18 in women who were not infected with either at baseline.

At the final analysis, 60 cases of cervical intraepithelial neoplasia were confirmed, of which 33 contained DNA from nonvaccine oncogenic HPV types as well as HPV 16 or HPV 18.

Of those, four were in the vaccine group and 56 in the control group, the researchers found, for a vaccine efficacy rate of 93%.

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Many women in the study were infected with nonvaccine oncogenic strains of HPV, and in a post hoc analysis, the researchers estimated a cross-protective efficacy that could represent between 11% and 16% additional protection against cervical cancer.

In considering Merck’s request to extend Gardasil’s approval to males, the committee voted 7-0 that data support the vaccine’s effectiveness in preventing genital warts caused by HPV types 6 and 11. The vote was 7-1 on the safety of the vaccine. FDA staff papers likewise favored the endorsement.

HPV in males can produce skin warts, genital warts, penile intraepithelial neoplasia, penile cancer, anal intraepithelial neoplasia, anal cancer, oropharyngeal cancer, and recurrent respiratory papillomatosis, but Merck’s current application is just for the prevention of genital warts.

Genital warts are the most common presenting complaint in both males and females with HPV. About 1% of the entire U.S. sexually active population is estimated to have genital warts. About 200 per 100,000 males are newly diagnosed with genital warts each year, according to the FDA.

Most genital warts are caused by genital infection with HPV, particularly types 6 and 11 which are found in 70% to 100% of lesions.

The sponsor is seeking approval based on a phase III study of 4,065 boys and men who were randomized to receive the three-dose Gardasil vaccine or placebo.

Each patient underwent a genitourinary exam, had specimens collected for HPV, and underwent a lesion biopsy if indicated at months 7, 12, 18, 24, 30, and 36. Sera were collected for immunogenicity at screening and at months 7, 24, and 36.

Although the primary endpoint of the study was external genital lesions — including penile, perianal, and perineal intraepithelial neoplasia (PIN), as well as genital warts — the data showed that most lesions were actually warts and that there were very few cases of PIN, so Merck and the FDA agreed to focus the application only on genital warts.

The vaccine offered a nearly 90% protection against genital warts. In the vaccine group, three out of 1,397 patients became infected with HPV, and in the control group, 28 patients out of 1,408 became infected over the course of the study.

“Data submitted … demonstrate that Gardasil is efficacious in the prevention of genital warts caused by HPV 6 and 11 in males 16 to 26 years of age,” concluded staff from FDA’s Center for Biologics Evaluation and Research.

The vaccine was more effective in those between the ages of 15 and 20 than in those 21 to 27 (94% versus 85%). Efficacy didn’t appear to decrease as number of sexual partners increased.

Gardasil efficacy was greater in men who have sex with women than in men who have sex with men (92% versus 79%).

Among those with preexisting HPV infections, the vaccine was markedly less effective.

Merck also submitted results from a study to demonstrate the noninferiority of antibody responses among younger females to older females (and to extrapolate those findings to males), and a study to demonstrate that the vaccine has a similar antibody response in males and females.

FDA staffers said Gardasil was found to be safe, and no deaths that occurred during the study were attributed to the vaccine.

According to the briefing documents, a “comprehensive discussion of prevention and treatment of HPV in males would also include estimates of the impact on transmission to females,” but Merck’s data was not that far-reaching.

Source: Medpage TODAY

Popularity: 6% [?]